MAUDE Adverse Event Report: Nova Biomedical Corporation Statstrip; Glucose monitoring system IVD, point-of-care

Model Number	2.0
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The consumer reported patient results transmitted to another chart.
Additional Manufacturer Narrative
This incident was initially determined to be non-reportable.However, a report is being submitted at the direction of the fda.No allegations of patient mistreatment were reported.Although the customer did not explicitly identify patient harm, the reported issue could potentially result in delayed or inappropriate treatment.This complaint is currently under formal investigation by nova biomedical.Field safety notice 02-26ng was issued to notify affected customers of the issue.A supplemental report will be submitted upon completion of the investigation.

• Brand Name: Statstrip
• Common Device Name: Glucose monitoring system IVD, point-of-care
• Manufacturer (Section D): Nova Biomedical Corporation; 200 prospect street; waltham MA 02454
• Manufacturer (Section G): Nova Biomedical Corporation; 165 lexington rd; billerica MA 01821
• Manufacturer Contact: lyra rem ; 39 manning rd; billerica, MA 01821 ; +1(978)439-3682
• MDR Report Key: 50867189
• Report Number: 1219029-2026-00060
• Device Sequence Number: 18486781
• Product Code: PZI
• UDI-Device Identifier: 00385480636858
• UDI-Public: (01)00385480636858(11)251230
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K232075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 09/23/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 2.0
• Device Catalogue Number: 63685
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/30/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-3128-2026 thru Z-3132-
• Patient Sequence Number: 1
• Patient Sex: Unknown